CAPA software

»CAPA Management — Corrective And Preventive Actions«

Software for your CAPA processes

Con­trol your pro­duc­tion-re­la­ted QM pro­ces­ses such as cor­rec­ti­ve and pre­ven­ti­ve ac­tions (CAPA) with our di­gi­tal work­flows. Our in­te­gra­ted so­lu­ti­ons ma­na­ge your pre­vious­ly pa­per-bound pro­cess from cap­tu­re to com­ple­ti­on com­ple­te­ly di­gi­tal­ly. The work­flow sys­tem au­to­ma­ti­cal­ly for­wards the di­gi­tal form to the next in­s­tance; if dead­lines are ex­cee­ded, the re­min­der and es­cala­ti­on ma­nage­ment ta­kes ef­fect. Of cour­se, an ab­sence ma­nage­ment is also in­cluded for the task routing.

Illustration of a notebook on which the QM-workflows of Digital Life Sciences are displayed

How can you benefit from the CAPA software?

Process safety 

Af­ter each step, the work­flow sys­tem en­su­res that the CAPA is for­ward­ed to the per­son in char­ge. The es­cala­ti­on sys­tem ta­kes ef­fect in case of missed deadlines. 

Data integrity 

Cor­rec­ti­ve and pre­ven­ti­ve ac­tions (CA­PAs) are no lon­ger lost be­cau­se they are stored di­gi­tal­ly from the be­gin­ning. You also pro­tect your data from un­wan­ted in­ter­fe­rence of un­aut­ho­ri­zed users and from de­s­truc­ti­ve forces. 

Constant availability 

Ac­cess your data at any time. It does not mat­ter whe­re you are. 

Central information platform 

Use d.velop do­cu­ments (form­er­ly d.3ecm) as your cen­tral in­for­ma­ti­on plat­form on which you can re­trie­ve all your data at short notice. 


CA­PAs can be lin­ked to other mo­du­les such as Ch­an­ge Con­trol. Thus a traceable chain of in­ter­re­la­ted in­di­vi­du­al pro­ces­ses is crea­ted. CA­PAs can be in­itia­ted, for ex­am­p­le, from de­via­ti­on re­ports or can in­itia­te a ch­an­ge process. 


Every aut­ho­ri­zed em­ployee sees the cur­rent sta­tus of all CAPA pro­ces­ses – even if he or she is not in­vol­ved in the process. 

Individual configuration 

Let the mo­du­les be con­fi­gu­red ac­cor­ding to your wis­hes and pre­fe­ren­ces to fa­ci­li­ta­te the on­boar­ding trai­ning for your colleagues. 


Crea­te re­ports and sta­tis­tics about your CAPAs. 

Get a first overview.

Illustration of a notebook on which the QM-workflows of Digital Life Sciences are displayed
PDF Do­cu­ment

The di­gi­tal forms are also con­ver­ted to a PDF/A in par­al­lel. This way, em­ployees who are not in­vol­ved in the pro­cess can also gain in­sight into the work­flow and the do­cu­ment can be shared with ex­ter­nal par­ties if required.

dls | capa

What is a CAPA process?

The CAPA pro­cess (Cor­rec­ti­ve and Pre­ven­ti­ve Ac­tion) al­lows drug safe­ty errors/deviations to be sys­te­ma­ti­cal­ly re­cor­ded and pro­ces­sed in con­for­mi­ty with re­gu­la­to­ry and in­ter­nal spe­ci­fi­ca­ti­ons. In the pro­cess, CAPA ma­nage­ment fo­cu­ses on the eli­mi­na­ti­on of non­con­for­mi­ties (cor­rec­ti­ve ac­tion) and the avo­id­ance of po­ten­ti­al non­con­for­mi­ties (pre­ven­ti­ve action).

Non­con­for­mi­ties fol­low, for ex­am­p­le, from a pro­cess de­via­ti­on that re­sults in cer­tain cor­rec­ti­ve ac­tions that can eli­mi­na­te the exis­ting problem.

For ex­am­p­le, a pre­ven­ti­ve me­a­su­re could re­sult from an OOT ana­ly­sis. No ac­tu­al non­con­for­mi­ty has oc­cur­red here yet, but a de­gra­da­ti­on of the va­li­da­ted pro­cess has been noted.

The CAPA pro­cess can thus en­su­re con­ti­nuous pro­duct quality.

Au­dit Trail

Every ac­tion in the pro­cess is au­to­ma­ti­cal­ly do­cu­men­ted by the sys­tem ac­cor­din­gly. In­te­gra­ted au­dit trail func­tions en­su­re high traceability.


The di­gi­tal form is fil­led out step by step and pro­vi­ded with the re­le­vant ent­ries and data. Fields with a blue back­ground are man­da­to­ry. Pre­de­fi­ned va­lue sets and drop-down func­tions make it easy for users to fill out the form.

Pro­cess Steps

Af­ter pro­ces­sing the in­di­vi­du­al steps (1. In­itia­ti­on, 2. Re­cor­ding of me­a­su­res and risks, 3. Ex­pert com­mit­tee, etc.), the work­flow sys­tem au­to­ma­ti­cal­ly sends tasks and mes­sa­ges to the re­spon­si­ble agents or work­flow par­ti­ci­pan­ts. Once all steps have been pro­ces­sed, the work­flow is con­side­red complete.

1st Step: In­itia­ti­on
The in­itia­ti­on of the CAPA is done by the pro­cess re­spon­si­ble of the con­cer­ned de­part­ment. He or she re­cords the re­le­vant data for CAPA. The pro­cess is then for­ward­ed to the ap­poin­ted CAPA responsible.

Would you like a live insight into the software?

Get a live in­sight into the pos­si­bi­li­ties of the pro­duc­tion-re­la­ted QM pro­ces­ses in just 45 mi­nu­tes with a sam­ple use case. Learn how you can use the so­lu­ti­ons of Di­gi­tal Life Sci­en­ces to op­ti­mi­ze your pro­duc­tion-re­la­ted QM pro­ces­ses such as com­plaints (Com­plaint), de­via­ti­on re­ports (De­via­ti­on Con­trol), cor­rec­ti­ve and pre­ven­ti­ve ac­tions (CAPA) or ch­an­ge con­trols (Ch­an­ge Con­trol) with our di­gi­tal workflows.

Features of the Corrective And Preventive Actions software

Regulatory requirements in the CAPA process

33 Good reasons for a cooperation with Digital LS

You’re not con­vin­ced yet? Find out about 33 good re­asons spea­king for a co­ope­ra­ti­on with Di­gi­tal Life Sci­en­ces GmbH. We will show you re­asons from the provider’s point of view, from the soft­ware point of view and other ge­ne­ral re­asons that di­stin­gu­ish us.

Customer review on the CAPA Management

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The CAPA is a com­po­nent of the Di­gi­tal Life Sci­en­ces so­lu­ti­on suite. Each pro­duct is powerful on its own, but when used tog­e­ther they are even better.

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Document Control software

Whe­ther work / pro­cess in­s­truc­tions (SOPs), pro­cess de­scrip­ti­ons, test spe­ci­fi­ca­ti­ons or other ty­pes of do­cu­ments — you can crea­te, re­vi­se and sign them all di­gi­tal­ly with the do­cu­ment con­trol software.

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Training Management software

Ex­tend the “Do­cu­ment Con­trol” mo­du­le to ac­tively plan and re­cord the qua­li­fi­ca­ti­ons of your em­ployees with our trai­ning ma­nage­ment software.

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E‑learning software

Use the new soft­ware “E‑Learning” to train your em­ployees di­gi­tal­ly. Crea­te an e‑learning cour­se ac­cor­ding to your wis­hes using Mi­cro­soft Power­Point or in­te­gra­te exis­ting presentations.

Frequently asked questions (FAQs) about CAPA

In the ad­mi­nis­tra­ti­on, time spe­ci­fi­ca­ti­ons can be en­te­red for each pro­cess step. Re­min­der mes­sa­ges are sent be­fo­re the pro­cess steps are due. The re­min­der mes­sa­ge is sent to the pro­ces­sor of the task, the coor­di­na­tor and the con­fi­gu­red group that is to be in­for­med about the re­min­der (for ex­am­p­le, QA). A re­min­der is sent with the con­fi­gu­red subject.

If ad­di­tio­nal files are re­qui­red for a pro­cess, at­tach­ments can be uploa­ded in all pro­cess steps and lin­ked to the cur­rent pro­cess. The at­tach­ments are stored un­der a cor­re­spon­ding do­cu­ment type in the DMS and can be view­ed in CAPA un­der ‘At­tach­ments’ by all pro­cess par­ti­ci­pan­ts. You can con­fi­gu­re which file ty­pes can be sa­ved as at­tach­ments and how lar­ge the files can be.

It can be con­fi­gu­red so that the pro­cess can be can­cel­led at any pro­cess step. For the can­cel­la­ti­on, it is re­qui­red to in­di­ca­te a re­ason in a man­da­to­ry field. Only the coor­di­na­tor of the pro­cess is al­lo­wed to cancel.

Ha­ving en­te­red a me­a­su­re, you can save it as a tem­p­la­te in the me­a­su­re ta­ble. The tem­pla­tes are available for in­ser­ti­on in a CAPA. The due date for the me­a­su­re is cal­cu­la­ted ba­sed on the du­ra­ti­on en­te­red in the template.

In prin­ci­ple, a pro­cess step is com­ple­ted with an elec­tro­nic si­gna­tu­re and can no lon­ger be cor­rec­ted. With the func­tion ‘Step back’ the pro­cess can be re­tur­ned to a pre­vious pro­cess step. The user who has com­ple­ted this step re­cei­ves it again for editing and the pro­cess con­ti­nues from this step. Any re­turn to a pre­vious step is re­cor­ded in the au­dit trail.

In all pro­cess steps that fol­low the in­itia­ti­on, you can for­ward the pro­cess step to an­o­ther per­son. The recipient’s aut­ho­riza­ti­on is che­cked du­ring the selection.

The es­sen­ti­al data of a CAPA is trans­fer­red to the at­tri­bu­tes of the data re­cord. This al­lows you to search and ana­ly­ze the CA­PAs you have crea­ted. The ana­ly­ses can be ex­por­ted as PDF, EXCEL or WORD documents.

The CAPA pro­cess flow has been de­si­gned in ac­cordance with the GxP re­gu­la­ti­ons and crea­ted in con­sul­ta­ti­on with QM ex­perts. Against the back­ground of the va­li­da­ti­on do­cu­men­ta­ti­on, the pro­cess steps are the­r­e­fo­re man­da­to­ry. Ho­we­ver, each pro­cess step con­ta­ins a ‘Cus­tom Pa­nel’, which can be used to dis­play fur­ther in­for­ma­ti­on or in­itia­te actions.

In the work­flow ad­mi­nis­tra­ti­on, you can con­fi­gu­re the names of the pro­cess steps, field names and datasets.

When working on a pro­cess step, only this step can be pro­ces­sed, but the other pro­cess steps are still visible.

Quick contact

Do you have a ques­ti­on about the CAPA mo­du­le?
Our sa­les team will help you prompt­ly and gladly.